Approval follows the positive opinion granted
by European Committee for Medicinal Products for Human Use (CHMP)
in July 2022
LUPKYNIS is the first oral medicine approved in
both the U.S. and Europe for the treatment of adults living with
active lupus nephritis
Approval triggers $30.0 million milestone
payment, to be recognized as revenue in the 3rd quarter
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the
Company), a biopharmaceutical company committed to delivering
therapeutics that change the trajectory of autoimmune disease,
announced that the European Commission (EC) has granted marketing
authorization of LUPKYNIS® (voclosporin) to treat adults with
active lupus nephritis (LN), a serious complication of systemic
lupus erythematosus (SLE). The U.S. Food and Drug Administration
(FDA) approved LUPKYNIS on January 22, 2021, in combination with a
background immunosuppressive therapy regimen to treat adult
patients with active LN.
The centralized marketing authorization is valid in all European
Union (EU) member states as well as in Iceland, Liechtenstein,
Norway and Northern Ireland.
“Today marks the first approved oral treatment for lupus
nephritis in both the European Union and provides adults across
Europe living with this potentially life-threatening disease a new
treatment option,” said Peter Greenleaf, President and Chief
Executive Officer, Aurinia. “People with lupus nephritis and their
physicians have long been challenged by the lack of treatments
available. In partnership with Otsuka, we’re excited to reach
patients across Europe with a meaningful therapy that can help
enable positive long-term kidney outcomes.”
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a
collaboration and licensing agreement in December 2020 for the
development and commercialization of voclosporin for the treatment
of LN in the EU, Japan, the United Kingdom, Russia, Switzerland,
Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of
the agreement, Aurinia will receive a $30.0 million EC
approval-related milestone payment to be recognized as revenue in
the quarter, with receipt of cash to follow within 30 days of
invoicing. In addition to the milestone payment, Aurinia is
eligible to receive further payments tied to additional regulatory
and reimbursement milestones, low double-digit royalties on future
net sales, as well as revenues for the supply of product to Otsuka
under a cost-plus arrangement.
A decision on marketing authorization for LUPKYNIS in Great
Britain is expected from the UK Medicines and Healthcare products
Regulatory Agency in the coming weeks. In addition, a marketing
authorization application (MAA) for LUPKYNIS was submitted to the
Swiss Agency for Therapeutic Products (Swissmedic) and is currently
under review. Swissmedic previously granted orphan drug status to
voclosporin in LN in February 2022.
The EC approval of LUPKYNIS is based on the results of the
pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation
study, which demonstrated voclosporin, in combination with
mycophenolate mofetil (MMF) and low-dose corticosteroids, led to
statistically superior complete renal response rates at 52 weeks
compared to MMF and low-dose corticosteroids alone. The safety
profile of voclosporin and MMF and low-dose corticosteroids was
generally comparable to MMF and low-dose corticosteroids alone.
About Lupus Nephritis
LN is a serious manifestation of SLE, a chronic and complex
autoimmune disease. About 200,000-300,000 people live with SLE in
the U.S. and about one-third of these people are diagnosed with
lupus nephritis at the time of their SLE diagnosis. About 50
percent of all people with SLE may develop lupus nephritis. If
poorly controlled, LN can lead to permanent and irreversible tissue
damage within the kidney. Black and Asian individuals with SLE are
four times more likely to develop LN and individuals of Hispanic
ancestry are approximately twice as likely to develop the disease
when compared with Caucasian individuals. Black and Hispanic
individuals with SLE also tend to develop LN earlier and have
poorer outcomes when compared to Caucasian individuals.
About LUPKYNIS
LUPKYNIS® is the first U.S. FDA-approved and EC-approved oral
medicine for the treatment of adult patients with active lupus
nephritis (LN). LUPKYNIS is a novel, structurally modified
calcineurin inhibitor (CNI) with a dual mechanism of action, acting
as an immunosuppressant through inhibition of T-cell activation and
cytokine production and promoting podocyte stability in the kidney.
The recommended starting dose of LUPKYNIS is three capsules twice
daily with no requirement for serum drug monitoring. Dose
modifications can be made based on Aurinia’s proprietary
personalized eGFR-based dosing protocol. Boxed Warning, warnings,
and precautions for LUPKYNIS are consistent with those of other
CNI-immunosuppressive treatments.
About Aurinia
Aurinia Pharmaceuticals is a fully integrated biopharmaceutical
company focused on delivering therapies to treat targeted patient
populations that are impacted by serious diseases with a high unmet
medical need. In January 2021, the Company introduced LUPKYNIS®
(voclosporin), the first FDA-approved oral therapy dedicated for
the treatment of adult patients with active lupus nephritis. The
Company’s head office is in Victoria, British Columbia, its U.S.
commercial office is in Rockville, Maryland. The Company focuses
its development efforts globally.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS
LUPKYNIS is indicated in combination with a background
immunosuppressive therapy regimen for the treatment of adult
patients with active LN. Limitations of Use: Safety and efficacy of
LUPKYNIS have not been established in combination with
cyclophosphamide. Use of LUPKYNIS is not recommended in this
situation.
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS
Increased risk for developing malignancies and serious
infections with LUPKYNIS or other immunosuppressants that may lead
to hospitalization or death.
CONTRAINDICATIONS
LUPKYNIS is contraindicated in patients taking strong CYP3A4
inhibitors because of the increased risk of acute and/or chronic
nephrotoxicity, and in patients who have had a serious/severe
hypersensitivity reaction to LUPKYNIS or its excipients.
WARNINGS AND PRECAUTIONS
Lymphoma and Other Malignancies: Immunosuppressants, including
LUPKYNIS, increase the risk of developing lymphomas and other
malignancies, particularly of the skin. The risk appears to be
related to increasing doses and duration of immunosuppression
rather than to the use of any specific agent.
Serious Infections: Immunosuppressants, including LUPKYNIS,
increase the risk of developing bacterial, viral, fungal, and
protozoal infections (including opportunistic infections), which
may lead to serious, including fatal, outcomes.
Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute
and/or chronic nephrotoxicity. The risk is increased when CNIs are
concomitantly administered with drugs associated with
nephrotoxicity.
Hypertension: Hypertension is a common adverse reaction of
LUPKYNIS therapy and may require antihypertensive therapy.
Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum
of neurotoxicities: severe include posterior reversible
encephalopathy syndrome (PRES), delirium, seizure, and coma; others
include tremor, paresthesia, headache, and changes in mental status
and/or motor and sensory functions.
Hyperkalemia: Hyperkalemia, which may be serious and require
treatment, has been reported with CNIs, including LUPKYNIS.
Concomitant use of agents associated with hyperkalemia may increase
the risk for hyperkalemia.
QTc Prolongation: LUPKYNIS prolongs the QTc interval in a
dose-dependent manner when dosed higher than the recommended lupus
nephritis therapeutic dose. The use of LUPKYNIS in combination with
other drugs that are known to prolong QTc may result in clinically
significant QT prolongation.
Immunizations: Avoid the use of live attenuated vaccines during
treatment with LUPKYNIS. Inactivated vaccines noted to be safe for
administration may not be sufficiently immunogenic during treatment
with LUPKYNIS.
Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA)
have been reported in patients treated with another CNI
immunosuppressant. If PRCA is diagnosed, consider discontinuation
of LUPKYNIS.
Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and
strong CYP3A4 inhibitors or with strong or moderate CYP3A4
inducers. Reduce LUPKYNIS dosage when co-administered with moderate
CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with
narrow therapeutic windows when co-administered.
ADVERSE REACTIONS
The most common adverse reactions (>3%) were glomerular
filtration rate decreased, hypertension, diarrhea, headache,
anemia, cough, urinary tract infection, abdominal pain upper,
dyspepsia, alopecia, renal impairment, abdominal pain, mouth
ulceration, fatigue, tremor, acute kidney injury, and decreased
appetite.
SPECIFIC POPULATIONS
Pregnancy/Lactation: May cause fetal harm. Advise not to
breastfeed.
Renal Impairment: Not recommended in patients with baseline eGFR
≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal
impairment: Reduce LUPKYNIS dose.
Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose.
Severe hepatic impairment: Avoid LUPKYNIS use.
Please see Prescribing Information, including Boxed Warning, and
Medication Guide for LUPKYNIS.
Forward-Looking Statements
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable
Canadian securities law and forward-looking statements within the
meaning of applicable United States securities law. These
forward-looking statements or information include but are not
limited to statements or information with respect to: Aurinia’s
estimate as to the timing of marketing authorization for Great
Britain; and Aurinia’s estimates as to the number of patients with
SLE in the U.S. and the proportion of those persons who have
developed LN at time of SLE diagnosis; Aurinia being confident that
it is poised for growth and success. It is possible that such
results or conclusions may change. Words such as “anticipate,”
“will,” “believe,” “estimate,” “expect,” “intend,” “target,”
“plan,” “goals,” “objectives,” “may” and other similar words and
expressions, identify forward-looking statements. We have made
numerous assumptions about the forward-looking statements and
information contained herein, including among other things,
assumptions about: the accuracy of reported data from third party
studies and reports; that Aurinia’s intellectual property rights
are valid and do not infringe the intellectual property rights of
third parties; assumptions related to timing of interactions with
regulatory bodies; and that Aurinia’s third party service providers
will comply with their contractual obligations. Even though the
management of Aurinia believes that the assumptions made, and the
expectations represented by such statements or information are
reasonable, there can be no assurance that the forward-looking
information will prove to be accurate.
Forward-looking information by their nature are based on
assumptions and involve known and unknown risks, uncertainties and
other factors which may cause the actual results, performance, or
achievements of Aurinia to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking information. Should one or more of these risks and
uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those described
in forward-looking statements or information. Such risks,
uncertainties and other factors include, among others, the
following: the market for the LN business may not be as estimated;
unknown impact and difficulties imposed by the COVID-19 pandemic on
Aurinia’s business operations including nonclinical, clinical,
regulatory and commercial activities; the results from Aurinia’s
clinical studies and from third party studies and reports may not
be accurate; Aurinia’s third party service providers may not, or
may not be able to, comply with their obligations under their
agreements with Aurinia; regulatory bodies may not grant approvals
on conditions acceptable to Aurinia and its business partners, or
at all; and Aurinia’s assets or business activities may be subject
to disputes that may result in litigation or other legal claims.
Although Aurinia has attempted to identify factors that would cause
actual actions, events, or results to differ materially from those
described in forward-looking statements and information, there may
be other factors that cause actual results, performances,
achievements, or events to not be as anticipated, estimated or
intended. Also, many of the factors are beyond Aurinia’s control.
There can be no assurance that forward-looking statements or
information will prove to be accurate, as actual results and future
events could differ materially from those anticipated in such
statements. Accordingly, you should not place undue reliance on
forward-looking statements or information. All forward-looking
information contained in this press release is qualified by this
cautionary statement. Additional information related to Aurinia,
including a detailed list of the risks and uncertainties affecting
Aurinia and its business, can be found in Aurinia’s most recent
Annual Report on Form 10-K available by accessing the Canadian
Securities Administrators’ System for Electronic Document Analysis
and Retrieval (SEDAR) website at www.sedar.com or the U.S.
Securities and Exchange Commission’s Electronic Document Gathering
and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on
Aurinia’s website at www.auriniapharma.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220919005617/en/
Investors DeDe Sheel dsheel@auriniapharma.com
Media aurinia@healthandcommerce.com
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Historical Stock Chart
From Feb 2024 to Mar 2024
Aurinia Pharmaceuticals (NASDAQ:AUPH)
Historical Stock Chart
From Mar 2023 to Mar 2024